- I. MAIN PROVISIONS
- II. NATIONAL REFERENCE LABORATORY ANDPERFORMANCE OF THE TASKS OF PUBLIC INTEREST
- III. REGISTRATION OF PLANT PROTECTION PRODUCTS
- IV. CIRCULATION OF PLANT PROTECTION PRODUCTS
- V. IMPORTATION OF PLANT PROTECTION PRODUCTS, ACTIVESUBSTANCES AND/OR BASIC SUBSTANCES
- VI. APPLICATION OF PLANT PROTECTION PRODUCTS
- VII. SERVICES RELATED TO PLANT PROTECTION PRODUCTS
- VIII. EXPERT COUNCIL FOR PLANT PROTECTION PRODUCTS
- IX. PROFESSIONAL EDUCATION
- X. RECORDS, DATA COLLECTION AND EXCHANGE
- XI. FUNDS FOR IMPLEMENTATION OF THE LAW
- XII. SUPERVISION
- XIII. PENAL PROVISIONS
- XIV. TRANSITIONAL AND FINAL PROVISIONS
1
LAW ON PLANT PROTECTION PRODUCTS
I. MAIN PROVISIONS
Scope of Regulation This Law shall govern the registration, control, circulation, importation, and application of plant protection products in agriculture and forestry, the tasks of public interest in the area of plant protection products, and other issues relevant for plant protection products.
Plant Protection Products Plant protection products, for the purpose of this Law, shall be:
1) Plant protection products;
2) Products of general use for plant protection;
3) Ancillary plant protection products;
4) Other plant protection products which contain one or more basic substances (hereinafter referred to as: other products).
Plant protection products, for the purpose of this Law, shall be deemed to be also plant protection products which are used in organic production and the plant protection products which contain or are composed of genetically modified organisms, or which are obtained from them, provided that the intentional introduction into the environment, placement into circulation or transit of such organisms is allowed based on the assessment of risk to the environment and human health, in accordance with the law governing genetically modified organisms.
Meaning of Terms Terms used in this Law shall have the following meaning:
1) Active substance shall mean a substance or a microorganism, including viruses, which has a general or specific effect on harmful organisms, plants, parts of plant or plant organisms;
2) Plants shall be deemed to be live plants and live parts of plants, including fresh fruit and seeds;
3) Plant products shall mean the products of plant origin in unprocessed state or having undergone simple reprocessing through milling, drying or pressing, excluding plants referred to in item 2) of this Article;
4) Distributor shall mean a legal person or entrepreneur that engages in circulation of plant protection products without altering their characteristics;
5) Good agricultural practice shall mean the performance of agricultural activities in a manner enabling the management of agricultural land and reproductive
material with respect of the natural characteristics of the agricultural area concerned and optimal combination of agrotechnical measures with the aim of conserving natural fertility of the agricultural land and preventing excessive pollution of the environment, excessive use of plant nutrition products and soil enrichment products and plant protection products, to ensure that the produced plants or plant products intended for consumption contain the least possible level of residue;
6) Animals shall mean those animal species which fall within the species usually fed, kept or consumed by humans;
7) Environment shall mean the water, air, soil, flora, fauna and their mutual relations;
8) Integrated plant protection shall mean rational application of a combination of biological, biotechnological, chemical, agrotechnical or enrichment measures for plant cultivation, where the application of chemical products is limited to the lowest possible extent necessary for maintenance of the population of harmful organisms below the level which may cause economically unacceptable damage;
9) Uniform principles shall mean the uniform criteria for assessment of active substance and/or basic substance and plant protection products, and for decision making in accordance with the contemporary international methodology;
10) Waiting period shall mean the final deadline for the application of plant protection products before harvesting;
11) User shall mean a legal person, entrepreneur or natural person that applies the plant protection products;
12) List of approved active substances and basic substances (hereinafter referred to as: the List of Approved Substances) shall mean an inventory of active substances and/or basic substances approved for use in plant protection products, which is adjusted to the list of active substances and basic substances in the territory of the European Union;
13) List of prohibited active substances and basic substances (hereinafter referred to as: the List of Prohibited Substances) shall mean an inventory of active substances and/or basic substances prohibited for use in plant protection products, which is adjusted to the list of active substances and basic substances in the territory of the European Union;
14) Maximum allowed quantity of residue shall mean the largest quantity of the plant protection products residue, expressed in mg/kg of the tested product;
15) Basic substance shall mean a substance which was not originally produced as a plant protection product but which manifests a certain biological activity;
16) Residues of plant protection products shall mean one or more active substances or basic substances or other substances, including their metabolites and products derived by their disintegration or reaction, which are present on plants or in plants, or on products of plant origin or in products of plant origin, or in edible products of animal origin, or anywhere in the environment (air, water, soil), and which result from the application of plant protection products;
17) Ancillary plant protection product shall mean a product containing one or more substances of natural or synthetic origin in its final form, which is used together with a plant protection product;
18) Preparation shall mean a mixture or a solution of substances intended to be used as a plant protection product, of which at least one substance is active substance;
19) Plant protection product shall mean an active substance or a preparation containing one or more active substances in its final form, which is intended for:
-Protection of plants or plant products from harmful organisms, or for prevention of any effects of harmful organisms;
-Affecting the life processes of plants in a manner different from the effects of the plant nutrition products such as plant development and growth regulators;
-Protection of plant products during warehousing, applied before or after harvesting, except for preserving agents;
-Destruction of unwanted plants or parts thereof.
20) product of general use for plant protection shall mean a preparation, other product or ancillary product prepared for direct application on small surfaces, the application of which does not present any danger for users and does not require wearing any personal protective gear;
21) Manufacturer shall mean a legal person or entrepreneur engaged in the production of plant protection products;
22) Circulation shall mean any supply of plant protection products, with or without compensation, including the importation in the territory of the Republic of Serbia, excluding warehousing for the purpose of exportation from the customs territory of the Republic of Serbia or warehousing for the purpose of their safe disposal;
23) Registration of plant protection products shall mean a procedure based on which a decision is issued permitting production, placement into circulation and application of plant protection products;
24) Substance shall mean a chemical element or its compounds, which appear in nature or as a result of a production process, including any impurities resulting from the production process;
25) Technical product shall mean a material containing active substance and impurities resulting from its production, and which may also contain a necessary quantity of additives;
26) Transit shall mean any transportation of the shipment across the territory of the Republic of Serbia;
27) Importation of plant protection products (hereinafter referred to as: the importation) shall mean any introduction of shipment to the territory of the Republic of Serbia, excluding transit;
28) Application appliances shall mean machines, apparatus and equipment, including their integral parts, which are designed for proper application of preparations, products of general use and ancillary plant protection products in the open or in closed space, as well as for the treatment of seed;
29) Harmful organisms shall mean organisms of plant or animal kingdom, viruses, bacteria, mycoplasma (phytoplasma) and other pathogenic organisms harmful for plant and plant products.
Application of Other Regulations A plant protection product, active substance and/or basic substance contained in the plant protection product may be produced, placed into circulation and applied in the territory of the Republic of Serbia if it is registered or entered in the List of Approved Substances in accordance with this Law and regulation enacted within the framework of it, and classified, packaged, labeled and accompanied with a safety paper, declaration and the instructions for use in accordance with this Law and regulations adopted based on this Law and in accordance with regulations enacted within the framework of it.
The plant protection products which are not registered in the Republic of Serbia, as well as the active substances and/or basic substances contained in plant protection products, but which are not entered in the List of Approved Substances, may be produced and warehoused in the Republic of Serbia, or imported and transported across the territory of the Republic of Serbia only if they are intended for placement into circulation in the country to which they are being exported.
Plant protection products shall be classified, packed, and mark in accordance with this Law and regulations adopted on the basis of it in accordance with the rules that regulate chemicals that are applied on the content and delivery of the security list.
Plant protection products, active substance and/or basic substances which are placed into circulation contrary to the provisions of this Law and regulations adopted based on this Law, as well as the plant protection products packaging shall be deemed to be waste.
The testing of properties and effects of active substances and/or basic substances and plant protection products on the health of humans, animals and the environment must be conducted in the laboratories which are in conformity with the guidelines of good laboratory practice, in accordance with the law governing medicines and medical devices.
II. NATIONAL REFERENCE LABORATORY AND PERFORMANCE OF THE TASKS OF PUBLIC INTEREST
National Reference Laboratory The work of laboratory testing and related activities in the field of plant protection is executed by the National reference laboratory, established by the law which regulates the food safety.
Tasks of Public Interest Tasks of public interest in the area of registration, placement into circulation and application of plant protection products and application appliances shall include the following scientific and expert tasks:
1) Testing of plant protection products, active substances and basic substances in the registration procedure;
2) Assessment of plant protection products, active substances and basic substances in the registration procedure;
3) Monitoring the residues of plant protection products in food and feed and the environment;
4) Scientific and expert support in decision making in the plant protection products registration procedure and determination of the maximum allowed quantity of residues;
5) Laboratory testing of samples of plant protection products taken in the procedure of inspection control with the aim of checking chemical and physical properties;
6) Control testing of application appliances;
7) Applied and other research in the area of plant protection products;
8) Development, establishment and application of new procedures in the good practice in plant protection and good agricultural practice;
9) Introduction of international standards in testing of the efficiency of plant protection products;
10) Professional training for the persons responsible for warehousing, placement into circulation and application of plant protection products and application appliances;
11) Records of the consumption, application of plant protection products and outstanding quantity of plant protection products;
12) Preparing the scientific basis for legal drafting in the area of plant protection products;
13) Other tasks in the area of plant protection products.
Public Bid for the Performance of the Tasks of Public Interest Article 7
The tasks of public interest in the area of plant protection products, may be assigned to legal persons through a public bid (hereinafter referred to as: the Legal Person Performing the Tasks of Public Interest) which shall be announced by the ministry responsible for agriculture (hereinafter referred to as: the Ministry) and published in the „Official Gazette of the Republic of Serbia”.
The performance of tasks of public interest referred to in Article 6 paragraph 1 items 1), 2), 3) and 5) may, based on the public bid, be assigned for a period of at least five years.
Public bid referred to in paragraph 1 of this Article shall include:
1) The tasks of public interest in the area of plant protection products for which the competition is being announced;
2) The period for which the performance of tasks of public interest is being assigned;
3) Evidence of compliance with the requirements in respect of technical and professional capacity, or accreditation, namely quality assurance in the organization and implementation of work in the laboratory and in the field, depending on the type of testing;
4) Criteria for the selection of the Legal Person Performing the Tasks of Public Interest;
5) Deadline for adoption and publication of the decision on selection of the Legal Person Performing the Tasks of Public Interest;
6) Manner of informing about the results of competition.
The public bid referred to in paragraph 1 of this Article shall be conducted by a commission established by the Minister.
The decision on selection of the Legal Person Performing the Tasks of Public Interest shall be issued by the Minister.
The results of competition shall be published in the „Official Gazette of the Republic of Serbia”.
Contract on Performance of the Tasks of Public Interest Based on the decision on selection of the Legal Person Performing the Tasks of Public Interest, the Ministry and the legal person who has been assigned the performance of tasks of public interest in the area of plant protection products shall conclude a contract which shall define, in particular:
1) The tasks of public interest which are subject of contract;
2) The responsible person who will perform specific tasks;
3) The methods, manner and procedure for performance of specific tasks;
4) Mutual rights, obligations and responsibilities;
5) Period for which the contract is concluded;
6) Manner of funding and price for the performance of specific tasks;
7) Control of the performance of specific tasks;
8) Termination of the contract;
9) Reasons for the termination of the contract;
10) Notice period for the termination of the contract.
Uniform Methods, Criteria and Guidelines for Performance of the Tasks of Public Interest Article 9
The Reference Laboratory shall organize and establish the application of uniform methods, criteria and guidelines for the performance of the tasks of public interest in the territory of the Republic of Serbia which are performed by the Legal Persons Performing the Tasks of Public Interest.
The Legal Persons Performing the Tasks of Public Interest shall perform the tasks of public interest in accordance with uniform methods, criteria and guidelines referred to in paragraph 1 of this Article.
III. REGISTRATION OF PLANT PROTECTION PRODUCTS
1. Registration Procedure
Applicant The Ministry shall register plant protection products based on the application for registration of plant protection products submitted by the manufacturer.
A manufacturer which has corporate domicile in the Republic of Serbia may submit the application for registration of plant protection products if it is entered in the Register of Economic Operators in accordance with the law governing the registration of economic operators and if it holds the evidence on compliance with the requirements for production of plant protection products in accordance with the regulations governing environmental protection.
A manufacturer which does not have corporate domicile in the Republic of Serbia shall submit the application for registration of plant protection products through an agent or a representative office established in the Republic of Serbia.
The agent of the manufacturer referred to in paragraph 3 of this Article must be entered in the Register of Economic Operators in accordance with the law governing the registration of economic operators and must have a contract on agency services which shall in particular define and ensure the liability for any damage arising from the application of plant protection products in the territory of the Republic of Serbia.
The representative office of the manufacturer referred to in paragraph 3 of this Article must be entered in the Register of Economic Operators in accordance with the law governing the registration of economic operators and the law governing foreign trade.
Application for Registration The manufacturer shall submit with the application for registration of plant protection products the following:
1) The documentation for assessment of active substances and/or basic substances contained in the plant protection products;
2) The documentation for assessment of plant protection products;
3) The sample of plant protection products, active substances and/or basic substances and other ingredients in plant protection products, in the original packaging;
4) The evidence on compliance with the requirements referred to in Article 10 paragraphs 2, 4 and 5.
The Minister shall prescribe the form and the content of the application for registration of plant protection products.
Documentation for Assessment of Documentation for the assessment of active substances and/or basic substances shall in particular contain the data about:
1) The identity of manufacturer;
2) The identity of active substances and/or basic substances;
3) The results of testing of physical and chemical properties;
Article 1
Article 2
Article 3
Article 4
Article 5
Article 6
Article 8
Article 10
Article 11
Active Substances and/or Basic Substances
Article 12